A Safety and Efficacy Study of Amdoxovir in HIV-1 Treatment-experienced Subjects.

Phase 2

Terminated

• Conditions: Human Immunodeficiency Virus Infection
• Interventions: Drug: amdoxovir 300 mg bid; Drug: amdoxovir 500 mg bid; Drug: tenofovir DF 300 mg qd

• Registration Number: NCT01737359
• Lead Sponsor: RFS Pharma, LLC

Brief Summary

This is a double-blind Phase 2a study to test the safety and efficacy of an investigational HIV drug, amdoxovir (300 mg or 500 mg twice daily) compared with tenofovir DF 300 mg once daily in HIV-1 infected antiretroviral therapy-experienced subjects who are currently failing antiretroviral therapy. There are three treatment groups (N=45). Subjects will be randomized to receive either amdoxovir 300 mg twice daily (n=15) or amdoxovir 500 mg twice daily (n=15) or tenofovir DF 300 mg once daily (n=15); each in combination with zidovudine 300 mg twice daily.

The study will assess initially amdoxovir (300 mg or 500 mg twice daily) or tenofovir DF 300 mg once daily, both in combination zidovudine 300 mg twice daily plus failing third drug, but then with lopinavir/ritonavir (400 mg/100 mg twice daily) after Week 2. Subjects who received amdoxovir (300 mg or 500 mg twice daily) and benefited from the drug may choose to enroll in the 36-week open-label study.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-27
• Study First Submitted QC: 2012-11-27
• Study First Posted: 2012-11-29
• Study Start: 2012-12
• Primary Completion: 2013-02
• Status Verified: 2013-03
• Study Completion: 2013-03
• Last Update Submitted: 2014-11-04
• Last Update Posted: 2014-11-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Male or female ≥ 18 years old with HIV-1 RNA ≥ 2,000 copies/mL and currently failing therapy.
• Has M184I/V mutation in addition to 0-2 thymidine analog mutations (TAMs) at screening.
• Agree to be abstinent or use two reliable forms of contraception (for females) and one form for men when participating in sexual activity that could result in pregnancy.

Exclusion Criteria

• Current or recent (last 30 days of study entry) AIDS defining diseases.
• Genotypic resistance testing at screening indicating K65R, L74V, Q151M mutation.
• Prior exposure to lopinavir/ritonavir or amdoxovir.
• Impaired hepatic function (ALT > 5 x ULN).
• Women who are pregnant or breast feeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amdoxovir 300 mg bid	amdoxovir 300 mg bid	in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
amdoxovir 500 mg bid	amdoxovir 500 mg bid	in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3
tenofovir DF 300 mg qd	tenofovir DF 300 mg qd	in combination with zidovudine 300 mg bid for 12 weeks; lopinavir/ritonavir (400 mg/100 mg) bid is added on week 3

Primary Outcome Measures

Name	Time	Method
HIV-1 viral load	change from baseline to Week 2
Safety and Tolerability- Incidence of adverse events and laboratory abnormalities	number and frequency from baseline through Week 12

Secondary Outcome Measures

Name	Time	Method
HIV-1 viral load	change from baseline to Weeks 4, 8 and 12
Changes in Immunologic Function (CD4 cell counts)	changes from baseline to Weeks 4, 8 and 12

Trial Locations

Locations (1)

Research Site; 🇦🇷 Buenos Aires, Argentina